Back to results

Evaluation for Benign and Malignant Pulmonary Ground-glass Nodules Based on MRI Dynamic Contrast Enhanced Imaging

Primary Purpose

Pulmonary Nodules

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

MRI scan

About this trial

This is an interventional diagnostic trial for Pulmonary Nodules

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Ground-glass pulmonary nodules found by CT scan
Plan to accept surgery or puncture due to the pulmonary nodules
Absence of treatment such as chemotherapy or radiotherapy and biopsy
Adequate renal function to tolerate intravenous gadolinium
Agree to sign informed consent
Able to lie still during DCE-MRI

Exclusion Criteria:

Fail to understand or agree to sign informed consent
Implanted pacemaker or cardiac defibrillator
Contraindications to undergoing MRI
Uncontrolled intercurrent illness
Pregnant or breastfeeding

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MRI scan

Arm Description

All participants will undergo 1 DCE-MRI scan before surgery or puncture.

Outcomes

Primary Outcome Measures

Volume transfer constant (Ktrans)

Pharmacokinetic parameters will be estimated by fitting a pharmacokinetic model to the actual time-intensity curves obtained from the DCE-MRI.

the fractional volume of extravascular extracellular space of the target tissue (ve)

Pharmacokinetic parameters will be estimated by fitting a pharmacokinetic model to the actual time-intensity curves obtained from the DCE-MRI.

the rate constant (kep)

Pharmacokinetic parameters will be estimated by fitting a pharmacokinetic model to the actual time-intensity curves obtained from the DCE-MRI.

Secondary Outcome Measures

Full Information

NCT ID

NCT05067023

First Posted

September 9, 2021

Last Updated

October 1, 2021

Sponsor

Qianfoshan Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05067023

Brief Title

Evaluation for Benign and Malignant Pulmonary Ground-glass Nodules Based on MRI Dynamic Contrast Enhanced Imaging

Official Title

Evaluation for Benign and Malignant Pulmonary Ground-glass Nodules Based on MRI Dynamic Contrast Enhanced Imaging

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Unknown status

Study Start Date

November 20, 2021 (Anticipated)

Primary Completion Date

December 15, 2022 (Anticipated)

Study Completion Date

March 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Qianfoshan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

Computed tomography (CT) is critical for the diagnosis of lung nodules as well as for therapeutic management. Repeated CT examinations will raise the issue of the cumulative radiation dose and subsequent risk of cancer, thus pushing the need for imaging techniques using low or no radiation dose. Magnetic Resonance Imagery (MRI) with ultrashort echo time (UTE) pulse sequences with high signal-to-noise and spatial resolution is a promising alternative for lung nodules imaging.The purpose of the study is to evaluate the value of dynamic contrast-enhanced MR imaging (DCE-MRI) to discriminate of malignant from benign lesions.

Detailed Description

Computed tomography (CT) is critical for the diagnosis of lung nodules as well as for therapeutic management. Repeated CT examinations will raise the issue of the cumulative radiation dose and subsequent risk of cancer, thus pushing the need for imaging techniques using low or no radiation dose. Magnetic Resonance Imagery (MRI) with ultrashort echo time (UTE) pulse sequences with high signal-to-noise and spatial resolution is a promising alternative for lung nodules imaging.The purpose of the study is to evaluate the value of DCE-MRI to discriminate of malignant from benign lesions.In this study, the investigators are going to validate the efficacy of the DCE-MRI for diagnosing early lung cancer by comparing results of the pre-surgery MRI imaging with the post-surgery pathology.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Nodules

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

MRI scan

Arm Type

Experimental

Arm Description

All participants will undergo 1 DCE-MRI scan before surgery or puncture.

Intervention Type

Diagnostic Test

Intervention Name(s)

MRI scan

Intervention Description

All participants will undergo 1 DCE-MRI scan.

Primary Outcome Measure Information:

Title

Volume transfer constant (Ktrans)

Description

Pharmacokinetic parameters will be estimated by fitting a pharmacokinetic model to the actual time-intensity curves obtained from the DCE-MRI.

Time Frame

12 months

Title

the fractional volume of extravascular extracellular space of the target tissue (ve)

Description

Pharmacokinetic parameters will be estimated by fitting a pharmacokinetic model to the actual time-intensity curves obtained from the DCE-MRI.

Time Frame

12 months

Title

the rate constant (kep)

Description

Pharmacokinetic parameters will be estimated by fitting a pharmacokinetic model to the actual time-intensity curves obtained from the DCE-MRI.

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Ground-glass pulmonary nodules found by CT scan Plan to accept surgery or puncture due to the pulmonary nodules Absence of treatment such as chemotherapy or radiotherapy and biopsy Adequate renal function to tolerate intravenous gadolinium Agree to sign informed consent Able to lie still during DCE-MRI Exclusion Criteria: Fail to understand or agree to sign informed consent Implanted pacemaker or cardiac defibrillator Contraindications to undergoing MRI Uncontrolled intercurrent illness Pregnant or breastfeeding

12. IPD Sharing Statement

Learn more about this trial

Evaluation for Benign and Malignant Pulmonary Ground-glass Nodules Based on MRI Dynamic Contrast Enhanced Imaging

We'll reach out to this number within 24 hrs